Suraxavir marboxil and oseltamivir to prevent flu spread in hospitals
Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting
This study will see if giving suraxavir marboxil or oseltamivir to hospital roommates of people with confirmed flu prevents them from getting infected.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 384 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Capital Medical University Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT07236814 on ClinicalTrials.gov |
What this trial studies
Hospitalized patients with confirmed influenza (index cases) and their uninfected roommates (room contacts) are enrolled at a Beijing tertiary hospital. Room contacts are randomized 1:1:1 to receive placebo, suraxavir marboxil, or oseltamivir and are monitored for new influenza infection. The primary outcome is the rate of influenza infection among room contacts during the follow-up period. The trial includes patients aged 2 years and older and uses rapid antigen or nucleic acid testing on respiratory specimens to confirm infections.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients aged 2 years or older who share a room with someone newly confirmed to have influenza and who can provide informed consent.
Not a fit: Patients who are already infected at enrollment, are not hospitalized at the study site, are under 2 years old, or have contraindications to the study antivirals are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could reduce in-hospital spread of influenza and protect vulnerable hospitalized patients.
How similar studies have performed: Oseltamivir has previously been shown to reduce influenza transmission in close-contact settings, while suraxavir marboxil is a newer antiviral whose prophylactic effect is less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
1.Inclusion Criteria:
(1)Inclusion Criteria for Index Cases:
① Patients hospitalized at a participating medical institution.
* The subject and/or their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.
* Age ≥ 2 years.
* Positive for influenza virus as determined by a Rapid Antigen Test (RAT) or Nucleic Acid Amplification Test (NAAT) on a respiratory specimen (e.g., oropharyngeal swab, nasopharyngeal swab, sputum, or bronchoalveolar lavage fluid).
(2) Inclusion Criteria for Room Contacts:
① Patients hospitalized at a participating medical institution.
* The subject and/or their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.
③ Age ≥ 12 years.
* Expected to remain hospitalized for ≥ 72 hours.
* Shares a room with at least one hospitalized index case who has been confirmed with influenza virus infection by RAT or NAAT on a respiratory specimen within the last 120 hours and developed influenza-related symptoms within the last 120 hours, and is expected to share the same room for ≥ 24 hours.
⑥ Negative for influenza virus as determined by a Nucleic Acid Amplification Test (NAAT) on a throat swab collected on Day 1.
3.Exclusion Criteria
(1) Index Cases There are no exclusion criteria for index cases. (2) Exclusion Criteria for Room Contacts:
* Room contacts with a known allergy to the active ingredients or excipients of the investigational drugs.
* Room contacts who have been diagnosed with or have had an influenza virus infection in the past 12 weeks.
* Use of any anti-influenza antiviral drugs within 2 weeks prior to screening, including: neuraminidase inhibitors, polymerase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers (e.g., Oseltamivir, Zanamivir, Peramivir, Favipiravir, Arbidol, Baloxavir Marboxil, Amantadine, or Rimantadine, or other anti-influenza drugs approved by the NMPA).
* Known to be pregnant or breastfeeding. (Subjects who suspect they may be pregnant must report this to the investigator, who will confirm with a pregnancy test).
* History of fever (axillary temperature ≥ 37.3°C) within 72 hours prior to screening.
* Child-Pugh class B or C, or an eGFR ≤ 60 mL·min-¹·(1.73 m²)-¹. ⑦ Any subject deemed unsuitable for participation in the study by the investigator.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- China-Japan Friendship hospital, Beijing, Beijing — Beijing, Beijing Municipality, China (Not_yet_recruiting)
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yeming Wang, Ph.D.
- Email: wwyymm_love@163.com
- Phone: +86 84206264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.